Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088959
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/02/1985 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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12/22/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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03/04/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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12/22/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/05/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/02/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/17/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/26/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/26/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |